Florida Nurses Association
Post Office Box 536985
Orlando, Florida 32753
407.896.3261
- Prohibits distribution of non-educational items (such as pens, mugs and other “reminder” objects typically adorned with a company or product logo) to healthcare providers and their staff. Gifts deemed to be educational items may not exceed $100 in value.
- Prohibits company sales representatives from providing restaurant meals to healthcare professionals, but allows them to provide occasional meals in healthcare professionals’ offices in conjunction with informational presentations. The Code also reaffirms and strengthens previous statements that companies should not provide any entertainment or recreational benefits to healthcare professionals.
- Companies may continue to sponsor Continuing Medical Education (CME) if the following guidelines are met:
- Any financial support should be given to the CME provider, which, in turn, can use the money to reduce the overall CME registration fee for all participants.
- The CME provider should follow standards for commercial support established by the Accreditation Council for Continuing Medical Education (ACCME) or other entity that may accredit the CME.
- The company should not provide any advice or guidance to the CME provider
- The company may not offer direct or indirect financial support to cover the costs of travel, lodging, or other personal expenses of non-faculty healthcare professionals attending CME
- Financial assistant for scholarships or other educational funds to permit medical students, residents, fellows, and other healthcare professionals in training to attend carefully selected educational conferences may be offered so long as the selection of individuals who will receive the funds is made by the academic or training institution.
- Companies may continue to obtain the services of professional consultants who provide advisory services if certain criteria for a bona fide consulting arrangement are met. Bona fide consultants may receive compensation as well as reimbursement for reasonable expenses associated with their services, however, speaking arrangements may not be used as inducements or rewards for prescribing behavior.
- Companies should require any healthcare professional who is a member of a committee that sets formularies or develops clinical guidelines and also serves as a speaker or commercial consultant for the company to disclose to the committee the existence and nature of his or her relationship with the company. This disclosure requirement should extend for at least two years beyond the termination of any speaker or consultant arrangement.
- Companies that choose to use non-patient identified prescriber data to facilitate communications with healthcare professionals should use the data responsibly.
- Follow the dosing recommendations exactly and use the measuring device that comes with the medicine,
- Do not give a medicine only intended for adults to a child,
- Do not use two medicines at the same time that contain the same ingredients,
- Prevent unsupervised ingestions by keeping all medicines out of the reach and sight of children,
- Do not use antihistamine products to make a child sleepy, and
- Consult a physician or healthcare professional with questions.
Prescriptive Authority in our state of Florida
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"Autism and Vaccines: The Today Show report"
Many of you may have heard about this Today Show segment, which aired yesterday, on vaccine-autism theorists. Dr. Nancy Snyderman does the report, including a profile of vaccine inventor and advocate Dr. Paul Offit. If you have not seen it, please click on the link below to view this report. It is worth watching until the very end...you will be surprised.
Thank you--
Gina Steiner
Director, Division of Public Information
AAP
Thanks,Janel Saunders, CPNP
President Florida Chapter of NAPNAP
Altamonte Pediatric Associates
janelps@yahoo.com
407.619.4385
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A summary of the "New PhRMA Guidelines" which explain expected changes in pharmaceutical representative relations with health ca
SAVE THE DATES: Application deadline for the NAPNAP Fly In Day and NIWI Scholarships is November 15th Registration for NAPNAP's 30th Annual Conference is now open! Mark your calendars for: Friday, March 20th 11:25 am – 12:25 pm Session 204: Child Health Advocacy 4:30 pm – 6:30 pm Legislative Networking Reception Saturday, March 21st 9:00 am – 10:00 am Session 304: Issue Focus: Top Federal Issues Facing PNPs
DON'T FORGET TO VOTE ON NOVEMBER 4th
These links will take you to McCain’s and Obama’s Health Reform Platforms. These are useful if you still need some help making up your mind.
New PhRMA Guidelines
Starting in January, pharmaceutical manufacturers will have many more restrictions on their interactions with health care professionals if they choose to adopt the new guidelines issued by the Pharmaceutical Research and Manufacturers of America (PhRMA). Although practitioners may still have regular visits from “drug reps,” they might notice a change in how “pharmaceutical detailers” deliver their respective messages. PhRMA is not the only trade group strengthening its provider protocols. AdvaMed, representing the medical device manufacturers along with other, international bodies are also examining their practices in the face of federal legislation and regulation that may ask companies to disclose their payments and gifts to health care professionals.
Among its changes, the revised PhRMA Code:
For more information on the new PhRMA Code on Interactions with Healthcare Professionals, please visit,http://www.phrma.org/code_on_interactions_with_healthcare_professionals/.
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American Academy of Pediatrics Updates Guidelines for Vitamin D Intake
News Author: Laurie Barclay, MD From American Academy of Pediatrics (AAP) 2008 National Conference and Exhibition October 14, 2008 — The American Academy of Pediatrics (AAP) has issued updated guidelines for vitamin D intake in infants, children, and teens to prevent rickets and vitamin D deficiency. The new recommendations were posted in the October 13 Early Release issue and will be published in the November 5 print issue ofPediatrics. The recommendations were also presented at the American Academy of Pediatrics 2008 National Conference and Exhibition in Boston, Massachusetts. The updated guidelines replace a 2003 AAP clinical report, which recommended a daily intake of 200 IU per day of vitamin D for all infants, from the first 2 months after birth, as well as for children and adolescents. The new recommendations call for a daily intake of 400 IU per day of vitamin D for all infants, children, and adolescents beginning in the first few days of life. "Rickets attributable to vitamin D deficiency is known to be a condition that is preventable with adequate nutritional intake of vitamin D," write Carol L. Wagner, MD, Frank R. Greer, MD, and the AAP Section on Breastfeeding and Committee on Nutrition. "Despite this knowledge, cases of rickets in infants attributable to inadequate vitamin D intake and decreased exposure to sunlight continue to be reported in the United States and other Western countries, particularly with exclusively breastfed infants and infants with darker skin pigmentation. Rickets, however, is not limited to infancy and early childhood, as evidenced by cases of rickets caused by nutritional vitamin D deficiency being reported in adolescents." The primary natural source of vitamin D is from skin synthesis from cholesterol after exposure to UVB light. Natural dietary sources of vitamin D are limited, and the amount of sunshine exposure sufficient for the cutaneous synthesis of vitamin D is not easily determined for a given individual. Furthermore, that amount of sunshine exposure may increase the risk for skin cancer. Therefore, the AAP has revised its 2003 recommendations to ensure adequate vitamin D status to include all infants, including those who are exclusively breast-fed, as well as older children and adolescents. All infants and children, including adolescents, should have a minimal daily intake of 400 IU of vitamin D beginning soon after birth, according to these revised guidelines. The current recommendation for healthy infants, children, and adolescents is based on findings from new clinical trials as well as on the historical precedent of safely administering 400 IU of vitamin D per day in the pediatric and adolescent populations. Furthermore, ingestion of 400 IU of vitamin D daily appears to treat as well as to prevent rickets. New data suggest that vitamin D has a potential role in maintaining innate immunity and in reducing the risk for certain chronic diseases including diabetes and cancer. This new evidence may eventually change the definition of vitamin D sufficiency or deficiency. Currently, vitamin D insufficiency in adults is defined as a level of 25-hydroxyvitamin D of 50 to 80 nmol/L and vitamin D deficiency as a level less than 50 nmol/L. Specific recommendations to ensure that healthy infants, children, and adolescents meet the required vitamin D intake of at least 400 IU per day are as follows: 1. Beginning in the first few days of life, breast-fed and partially breast-fed infants should be supplemented with 400 IU per day of vitamin D, and this should be continued unless the infant is weaned to at least 1 L per day or 1 quart per day of vitamin D–fortified formula or whole milk. Vitamin D levels in breast milk range from less than 25 to 78 IU/L, putting exclusively breast-fed infants at greater risk for vitamin D deficiency. Whole milk should not be given until the infant is at least 1 year old. Use of reduced-fat milk between ages 12 months and 2 years is appropriate in those children for whom overweight or obesity is a concern or for those with a family history of obesity, dyslipidemia, or cardiovascular disease. 2. A vitamin D supplement of 400 IU per day is indicated for all non–breast-fed infants and for older children who are consuming less than 1000 mL per day of vitamin D–fortified formula or milk. The daily intake of each child may include other dietary sources of vitamin D, such as fortified foods. 3. A vitamin D supplement of 400 IU per day is indicated for adolescents who do not ingest 400 IU of vitamin D per day from vitamin D–fortified milk (100 IU per 8-oz serving) and vitamin D–fortified foods (such as fortified cereals and egg yolks). 4. Serum concentrations of 25-hydroxyvitamin D in infants and children should be at least 50 nmol/L (20 ng/mL), based on the available evidence. 5. Despite ingesting 400 IU per day, children at increased risk for vitamin D deficiency, such as those with chronic fat malabsorption and those chronically treated with antiepileptic drugs, may continue to be vitamin D deficient. Children with dark skin pigmentation require 5 to 10 times longer to generate vitamin D3 from sunlight exposure. Children in these groups may require higher doses of vitamin D supplementation to achieve normal vitamin D status, which should be evaluated with laboratory tests for concentrations of serum 25-hydroxyvitamin D and parathyroid hormone and measures of bone mineral status. When a vitamin D supplement is prescribed, 25-hydroxyvitamin D levels should be monitored every 3 months, and parathyroid hormone and bone mineral status should be monitored every 6 months, until levels normalize. 6. Pediatricians and other healthcare professionals should ensure that vitamin D supplements are readily available to all children in their community, especially to those who are at greatest risk. Pregnant and lactating women who are vitamin D deficient may expose their offspring to a higher risk for vitamin D deficiency after birth and during lactation, and their vitamin D status should therefore be monitored. Although insufficient vitamin D intake in pregnant women adversely affects fetal skeletal development, tooth enamel formation, and general fetal growth, universal recommendations for high-dose vitamin D supplementation during pregnancy are not currently available. "Along with adequate vitamin D intake, calcium intake to achieve optimal bone formation and modeling must be ensured," the guidelines authors conclude. "A dietary history is essential in assessing the adequacy of dietary intake for various vitamins, minerals, and nutrients, including vitamin D and calcium. Children and adolescents at increased risk of developing rickets and vitamin D deficiency, including those with increased skin pigmentation, decreased sunlight exposure, chronic diseases characterized by fat malabsorption (cystic fibrosis, etc), and those who require anticonvulsant medications (which induce cytochrome P450 and other enzymes that may lead to catabolism of vitamin D) may require even higher doses than 400 IU/day of vitamin D." As with other AAP clinical reports, these guidelines automatically expire in 5 years unless reaffirmed, revised, or retired at or before that time. The recommendations in these guidelines are intended to prescribe an exclusive course of treatment or to serve as a standard of medical care. Variations in management considering individual patient circumstances may be appropriate. Pediatrics. Published online October 13, 2008. 2008;122:1142-1152.American Academy of Pediatrics Updates Guidelines for Vitamin D Intake
CME Author: Désirée Lie, MD, MSEd
Disclosures
Janel Saunders, CPNP
President Florida Chapter of NAPNAP
Altamonte Pediatric Associates
janelps@yahoo.com
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Statement from CHPA on the Voluntary Label Updates to Oral OTC Children's Cough and Cold Medicines
Children's over-the-counter (OTC) cough and cold medicines are safe and effective when used as directed, and the leading makers of these medicines are committed to working with the U.S. Food and Drug Administration (FDA) and pediatric experts to ensure that parents and caregivers have appropriate treatment choices for their children. Research shows that dosing errors and accidental ingestions—not the safety of the ingredients themselves when properly dosed—are the leading causes of rare adverse events in young children. As a result, the leading manufacturers of oral OTC pediatric cough and cold medicines are moving forward on both the design and implementation of initiatives aimed at encouraging the appropriate use of these medicines.
After consulting with FDA, the leading manufacturers of these medicines are voluntarily transitioning the labeling on oral OTC pediatric cough and cold medicines to state "do not use" in children under four years of age; these modified labels will continue to provide dosing information for children four and older. In addition, for products containing certain antihistamines, manufacturers are voluntarily adding new language that warns parents not to use antihistamine products to sedate or make a child sleepy. Adult cough and cold medicines are not impacted by the label update.
Throughout the 2008-2009 cough and cold season, manufacturers will be transitioning onto store shelves oral OTC pediatric cough and cold medicines with the new labels and packaging. As with other OTC labeling changes in the past, FDA has indicated it does not believe this labeling change warrants the removal of products with the existing labeling from store shelves during this time of transition.
Additionally, leading manufacturers already provide child-resistant packaging on all liquid pediatric cough and cold medicines to help reduce accidental ingestion and will provide dosing devices with each liquid medicine to help reduce dosing errors. These label updates and packaging enhancements reflect industry's overall commitment to the continued safe and appropriate use of children's oral OTC cough and cold medicines.
We also have expanded our national education program aimed at parents, caregivers, and healthcare professionals. The program focuses on educating parents and caregivers as follows:
Additionally, in consultation with the FDA and outside experts, manufacturers are conducting studies to reaffirm the effectiveness of oral OTC pediatric cough and cold medicines through pharmacokinetic studies to confirm appropriate dosing schedules for children and to validate the efficacy of these medicines with current and appropriate clinical trial designs.
For more information about CHPA's education campaign and more tips on safe dosing, visit www.OTCsafety.org
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